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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Management Systems, CAPA management, and regulatory compliance within clinical research and Medical Affairs. Proficient in managing third-party relationships and ensuring adherence to GxP requirements and audit processes.
Highest-signal resume keywords
Quality Management SystemsCAPA ManagementClinical Trial ExperienceRegulatory ComplianceVendor Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality AssuranceClinical ResearchRisk ManagementGxP RequirementsAudit ProcessesStudy ManagementRegulatory RequirementsClinical Data SystemsThird-Party ManagementMedical Affairs
Soft Skills
Problem-SolvingNegotiationConflict ResolutionDetail-OrientedMulti-Tasking
Tools & Technologies
TPM SystemsTPIATClinical Data Platforms
Industry Keywords
FDA RequirementsEMA RequirementsICH RegulationsPharmaceutical DevelopmentClinical Trial Processes
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Manage Quality Events (QEs), Quality Issues (QIs), deviations, and related investigations with relevant stakeholders
- Act as Deviation Owner, as appropriate, and support CAPA definition, implementation, tracking, effectiveness assessment, and closure
- Support internal and external audits, audit readiness activities, and remediation of audit findings
- Ensure quality records, supporting documentation, and evidence are complete, accurate, traceable, and inspection ready
- Support third-party governance and oversight activities from a quality and compliance perspective
- Support and contribute to third-party Quality Risk Assessments (QRAs) for GMA activities, including non-interventional studies, real-world evidence/data activities, Research Collaborations, and partnerships
- Follow up on identified risks and mitigation actions
- Identify, assess, and escalate risks arising from third-party due diligence, qualification, and oversight activities
- Ensure compliance with applicable SOPs, business guidance documents, quality standards, and regulatory requirements
- Support Research Collaboration and selected third-party non-vendor due diligence and assessment activities
- Ensure due diligence and assessment documentation is accurate and complete in TPM systems and tools
- Coordinate with internal stakeholders and third parties to obtain required due diligence information and documentation
- Support maintenance and continuous improvement of TPM due diligence tools, including TPIAT
- Lead or contribute as a subject matter expert to the design, revision, implementation, and improvement of V&TPM quality, compliance, governance processes, standards, procedures, and guidance
- Provide quality and compliance expertise, guidance, and training to operational teams and stakeholders
- Collaborate with Quality Assurance, Medical QA, Medical Governance & Risk Management, Procurement, Vendor & Partner Governance, and other stakeholders
Requirements
What you’ll need- Degree in a life science or healthcare-related discipline
- Previous experience in Vendor & Third-Party Management, Quality Assurance, Compliance, or a similar role supporting clinical research or Medical Affairs activities
- Clinical Trial/Medical Affairs experience in a pharmaceutical company or a Contract Research Organization (CRO) is required
- Experience working with external suppliers, research partners, and cross-functional stakeholders within a pharmaceutical company or CRO environment
- Experience with clinical/medical affairs processes and activities and associated external services, with excellent understanding of study management
- Strong understanding of clinical and Medical Affairs processes, study management activities, and associated external services
- Good knowledge of regulatory requirements in Clinical Research and drug development
- In-depth knowledge of the international pharmaceutical product development process
- Experience with GxP requirements, quality management systems including risk management, and regulatory requirements from main Health Authorities
- Broad understanding of FDA and EMA requirements, and ICH regulations and guidelines
- Strong understanding of Quality Management Systems, GCP/GVP requirements, audit processes, CAPA management, and risk management principles
- Understanding of procurement processes and clinical external suppliers landscape (CROs, Central Labs, specialty services, eCOA and new technologies)
- Experience and ability to manage/supervise third parties and external suppliers
- Good understanding of clinical data systems/platforms and overall integration of clinical data systems and processes
- Fluent written and spoken English
- Strong problem-solving, negotiation and conflict resolution skills
- Diligent, detail-oriented, accurate, accountable, multi-tasking, service-oriented, good with numbers